# C_2023223EN.01002801.xml

| 26.6.2023 | EN | Official Journal of the European Union | C 223/28 |
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26.6.2023

EN

Official Journal of the European Union

C 223/28

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Order of the General Court of 25 April 2023 — Klein v Commission

(Case T-562/19 RENV) (1)

(Actions for failure to act - Medical devices - Article 8(1) and (2) of Directive 93/42/EEC - Safeguard clause procedure - Notification by a Member State of a decision prohibiting the placing on the market of a medical device - Absence of a decision by the Commission - Repeal of Directive 93/42 - Articles 94 to 97 of Regulation (EU) 2017/745 - Market surveillance measures - Action manifestly well founded)

(2023/C 223/38)

Language of the case: German

Parties

Applicant: Christoph Klein (Großgmain, Austria) (represented by: H.-J. Ahlt, lawyer)

Defendant: European Commission (represented by: C. Hermes, E. Sanfrutos Cano and F. Thiran, acting as Agents)

Re:

By his action under Article 265 TFEU, the applicant asks the General Court to declare that the European Commission unlawfully failed to act in the safeguard clause procedure initiated on 7 January 1998 by the Federal Republic of Germany and to take a decision in accordance with Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), in relation to the ‘Inhaler Broncho-Air®’ device.

Operative part of the order

| 1. | The European Commission has failed to fulfil its obligations under Article 8(2) of Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices by failing to act in the safeguard clause procedure initiated on 7 January 1998 by the Federal Republic of Germany and to take a decision in accordance with Directive 93/42, replaced by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42, in relation to the Inhaler Broncho-Air® device. |
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1.

The European Commission has failed to fulfil its obligations under Article 8(2) of Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices by failing to act in the safeguard clause procedure initiated on 7 January 1998 by the Federal Republic of Germany and to take a decision in accordance with Directive 93/42, replaced by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42, in relation to the Inhaler Broncho-Air® device.

| 2. | The Commission shall pay the costs related to the appeal proceedings before the Court in Case C-430/20 P and those related to the initial proceedings in Case T-562/19 and to the proceedings referred back to the General Court in Case T-562/19 RENV. |
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2.

The Commission shall pay the costs related to the appeal proceedings before the Court in Case C-430/20 P and those related to the initial proceedings in Case T-562/19 and to the proceedings referred back to the General Court in Case T-562/19 RENV.

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(1)  OJ C 337, 7.10.2019.

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